Department of Gynecology, Erlangen University Hospital, Friedrich-Alexander University Erlangen-Nuremberg, Comprehensive Cancer Center Erlangen-EMN, Erlangen, Germany.
Department of Gynecology, Heinrich Heine University of Düsseldorf, Düsseldorf, Germany.
Ann Oncol. 2018 Jan 1;29(1):186-192. doi: 10.1093/annonc/mdx630.
Patients' compliance and persistence with endocrine treatment has a significant effect on the prognosis in early breast cancer (EBC). The purpose of this analysis was to identify possible reasons for non-persistence, defined as premature cessation of therapy, on the basis of patient and tumor characteristics in individuals receiving adjuvant treatment with letrozole.
The EvAluate-TM study is a prospective, multicenter, noninterventional study in which treatment with the aromatase inhibitor letrozole was evaluated in postmenopausal women with hormone receptor-positive EBC in the early therapy phase. Treatment persistence was evaluated at two pre-specified study visits after 6 and 12 months. As a measure of early therapy persistence the time from the start to the end of treatment (TTEOT) was analyzed. Cox regression analyses were carried out to identify patient characteristics and tumor characteristics predicting TTEOT.
Out of the total population of 3941 patients with EBC, 540 (13.7%) events involving treatment cessation unrelated to disease progression were observed. This was due to drug-related toxicity in the majority of cases (73.5%). Persistence rates were 92.2%, 86.9%, and 86.3% after 6, 12, and 15 months, respectively. The main factors influencing premature treatment discontinuation were older age [hazard ratio (HR) 1.02/year], comorbidities (HR 1.06 per comorbidity), low body mass index, and lower tumor grade (HR 0.85 per grade unit).
These results support the view that older, multimorbid patients with low tumor grade and low body mass index are at the greatest risk for treatment discontinuation and might benefit from compliance and support programs.
患者对内分泌治疗的依从性和持久性对早期乳腺癌（EBC）的预后有重要影响。本分析的目的是根据接受来曲唑辅助治疗的患者和肿瘤特征，确定非持久性（定义为提前停止治疗）的可能原因。
EvAluate-TM 研究是一项前瞻性、多中心、非干预性研究，评估了早期治疗阶段绝经后激素受体阳性 EBC 女性使用芳香化酶抑制剂来曲唑的治疗情况。在第 6 和 12 个月的两次预定研究访视时评估治疗持久性。将从治疗开始到结束的时间（TTEOT）作为早期治疗持久性的衡量标准进行分析。采用 Cox 回归分析来确定预测 TTEOT 的患者特征和肿瘤特征。
在 3941 例 EBC 患者中，有 540 例（13.7%）与疾病进展无关的治疗停止事件。这主要是由于药物相关毒性（73.5%）。治疗 6、12 和 15 个月后的持续率分别为 92.2%、86.9%和 86.3%。影响提前治疗停药的主要因素是年龄较大[风险比（HR）1.02/年]、合并症（每合并一种疾病 HR 增加 1.06）、低体重指数和肿瘤分级较低（每级 HR 降低 0.85）。
这些结果支持这样一种观点，即年龄较大、合并症较多、肿瘤分级较低且体重指数较低的患者停止治疗的风险最大，可能受益于依从性和支持计划。
